Novii+ Wireless Patch System— 510(k) K254036

Name: FDA 510(k) clearance K254036
Creator: U.S. Food and Drug Administration
Published: 2026-08-10

Substantially Equivalent

Datex Ohmeda, Inc.

FDA 510(k) clearance K254036 for Novii+ Wireless Patch System, Substantially Equivalent on 2026-08-10. Applicant: Datex Ohmeda, Inc.. Device class: 2.

Clearance details

Applicant: Datex Ohmeda, Inc.
Product code: Code HGM
Device class: Class 2
Regulation: 21 CFR 884.2740
Advisory panel: Obstetrics/Gynecology
Date received: 2025-12-16
Decision date: 2026-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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K213551 — Giraffe Omnibed Carestation CS12022-03-02
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Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.